Net clinical benefit of PFO closure versus medical treatment in patients with cryptogenic stroke: A systematic review and meta-analysis.

BACKGROUND: The ideal treatment for patent foramen ovale (PFO) in patients with cryptogenic stroke remains controversial and is being evaluated. The objective of this study was to evaluate the net clinical benefit (NCB) between PFO closure and medical treatment. METHODS: We searched three electronic databases from inception until January 2022. The primary outcomes were the NCB-1, defined as the cumulative incidence of stroke, major bleeding, atrial fibrillation/flutter, and serious procedural or device complications; the NCB-2 and NCB-3 were defined as NCB1 but using a weighted factor of 0.5 and 0.25 for atrial fibrillation/flutter events, respectively. We also evaluated each component outcome of NCB as a secondary outcome. Risk ratios (RR) and 95% confidence intervals (CI) of each outcome were calculated (random-effects model). RESULTS: Our analysis included six RCTs (n = 3750 patients). The rates of NCB-1, NCB-2, and NCB-3 were not different between PFO closure and medical treatment. The heterogeneity between trials was low to moderate. Stroke showed a significant relative decrease of 44% (95% CI, 21-60%), favoring the PFO closure arm. Atrial fibrillation/flutter increased by 4.04 times (95% CI, 1.57-8.89) in the PFO closure compared with the medical treatment group. In a meta-regression analysis, the reduction in NCB-1 with PFO closure increased as the proportion of patients treated with the Amplatzer device increased (p = 0.02), and the reduction in NCB-1, NCB-2, and NCB-3 with PFO closure increased as the proportion of patients treated with substantial PFO size increased (p = 0.03). CONCLUSION: The NCB between PFO closure and medical treatment was not different, suggesting individualized treatment to maximize benefit.

The Role of Pediatric BCG Vaccine in Type 1 Diabetes Onset.

INTRODUCTION: Bacille Calmette-Guérin (BCG) vaccination has shown promising therapeutic effects for type 1 diabetes (T1D). According to recent studies, immunometabolism modification and regulation of T lymphocytes constitute the proposed mechanisms by which BCG vaccination may delay T1D onset. Clinical trial evidence from Turkey supports that two to three doses of the BCG vaccine in childhood, with the first dose administered in the first year of life, may prevent T1D. In the same study, one or zero vaccinations appeared to have no effect in T1D onset prevention. In Greece, the BCG vaccine was administered in a single dose at the age of 9 years in elementary school. BCG vaccination was not performed on a mandatory basis, creating one BCG vaccinated and one non-vaccinated population. The aim of our study was to investigate the possible effect of a single dose of BCG vaccine, at the age of 9 years, on the time of T1D onset, in a population of BCG vaccinated and non-vaccinated patients with diagnosed T1D. METHODS: To test this hypothesis, a survey through the Pan-Hellenic Federation of People with Diabetes (PFPD) was performed. In this observational, retrospective study, participating patients provided information regarding age, gender, time of diagnosis, and BCG vaccination status. Patients diagnosed with T1D before the age of 9 years were excluded from the analysis. RESULTS: The final sample included 196 patients (73 male and 123 female) with a mean age of 42.2 ± 14.3 years and a mean duration of diabetes of 16.8 ± 12.9 years. Mean age of T1D diagnosis in the BCG vaccinated group was 24.0 ± 19.0 years, while the mean age of T1D diagnosis in the BCG non-vaccinated group was 21.5 ± 14.3 years (p = 0.03). No interaction was found between gender and the age of diagnosis for BCG vaccinated and unvaccinated patients (p = 0.86). CONCLUSION: The results of our study suggest that a single dose of BCG vaccine, performed at the age of 9 years, may delay the onset of T1D by 2.5 years. Additional studies of children receiving multiple doses of BCG should be conducted to possibly prove prolongation of the disease-free interval.

Changing the Concept: From the Traditional Glucose-centric to the New Cardiorenal-metabolic Approach for the Treatment of Type 2 Diabetes.

Type 2 diabetes mellitus (T2DM) is a chronic disease with a constantly increasing prevalence worldwide. It is well established that T2DM affects both the macro- and microvasculature, and its presence is associated with a high risk of acute and chronic cardiovascular events. Traditionally, the management of T2DM has been mainly focused on the optimization of blood glucose levels with the use of antidiabetic medications. During recent years, however, an impressive accumulation of evidence has arisen from studies designed to explore the plausible effects of new antidiabetic drugs on cardiovascular outcomes in patients with diabetes. This review article aims to emphasize the findings of these studies and to highlight the substantial role of the newer classes of antidiabetic drugs in treating T2DM in a holistic, cardiorenal-metabolic approach, thus shifting the paradigm from the traditional, simplistic, glucose-lowering approach.